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WHO Technical Report Series 946 THE This report presents the recommendations of the WHO Expert SELECTION THE SELECTION AND USE Committee responsible for updating the WHO Model List of Essential Medicines. The fi rst part contains a summary of the Committee’s OF ESSENTIAL MEDICINES considerations and justifi cations for additions and changes to the Model List, including its recommendations. Annexes to the main report include the revised version of the WHO Model List of Essential AND Medicines (the 15th) and a list of all items on the Model List sorted according to their 5-level Anatomical Therapeutic Chemical (ATC) USE classifi cation codes. Other annexes cover the proposed procedure for updating and disseminating the WHO Model List of Essential OF Medicines, and the revised procedure for updating the content ESSENTIAL of the Interagency Emergency Health Kit. Report of the WHO Expert Committee, 2007 MEDICINES (including the 15th Model List of Essential Medicines) WHO Technical Report ISBN 9789241209465 Series — 946 TRS946 cover.indd 1 28.11.2007 11:57:32 The World Health Organization was established in 1948 as a specialized agency of the United Nations serving as the directing and coordinating authority for SELECTED WHO PUBLICATIONS OF RELATED INTEREST international health matters and public health. One of WHO’s constitutional functions is to provide objective and reliable information and advice in the The international pharmacopoeia, fourth edition. fi eld of human health, a responsibility that it fulfi ls in part through its extensive Volume 1: general notices; monographs for pharmaceutical substances (A–O) programme of publications. The Organization seeks through its publications Volume 2: monographs for pharmaceutical substances (P–Z); monographs for dosage to support national health strategies and address the most pressing public health concerns of populations around the world. To respond to the needs of forms and radiopharmaceutical preparations; methods of analysis; reagents. Member States at all levels of development, WHO publishes practical manuals, 2006 (1500 pages), also available in CD-ROM format handbooks and training material for specifi c categories of health workers; inter- nationally applicable guidelines and standards; reviews and analyses of health Basic tests for drugs: pharmaceutical substances, policies, programmes and research; and state-of-the-art consensus reports that medicinal plant materials and dosage forms offer technical advice and recommendations for decision-makers. These books 1998 (94 pages) are closely tied to the Organization’s priority activities, encompassing disease prevention and control, the development of equitable health systems based Basic tests for pharmaceutical dosage forms on primary health care, and health promotion for individuals and communities. 1991 (134 pages) Progress towards better health for all also demands the global dissemination and exchange of information that draws on the knowledge and experience of Quality assurance of pharmaceuticals: a compendium all WHO’s Member countries and the collaboration of world leaders in public of guidelines and related materials. health and the biomedical sciences. To ensure the widest possible availability Volume 1: 1997 (244 pages) of authoritative information and guidance on health matters, WHO secures the Volume 2: Good manufacturing practices and inspection. broad international distribution of its publications and encourages their trans- 2nd updated edition, 2007 (in press) lation and adaptation. By helping to promote and protect health and prevent and control disease throughout the world, WHO’s books contribute to achieving the Quality control methods for medicinal plant materials Organization’s principal objective — the attainment by all people of the highest 1998 (123 pages) possible level of health. WHO Expert Committee on Specifi cations for Pharmaceutical Preparations Forty-fi rst report. WHO Technical Report Series, No. 943, 2007 (156 pages) The WHO Technical Report Series makes available the findings of various international groups of experts that provide WHO with the latest scientific International nonproprietary names (INN) for pharmaceutical substances. and technical advice on a broad range of medical and public health sub- Cumulative list no. 11. jects. Members of such expert groups serve without remuneration in their 2004 (available in CD-ROM format only) personal capacities rather than as representatives of governments or other bodies; their views do not necessarily reflect the decisions or the stated WHO Expert Committee on Biological Standardization policy of WHO. An annual subscription to this series, comprising about six Fifty-fi fth report. such reports, costs CHF 168.00/US$ 151.00 (CHF 128.40/US$ 115.00 in WHO Technical Report Series, No. 932, 2006 (146 pages) developing countries). For further information, please contact: WHO Press, World Health Organization, 20 avenue Appia, 1211 Geneva 27, Switzerland WHO model formulary (tel. +41 22 791 3264; fax: +41 22 791 4857; e-mail: [email protected]; 2006 (available in CD-ROM format only) order on line: http://www.who.int/bookorders). Further information on these and other WHO publications can be obtained from WHO Press, World Health Organization, 1211 Geneva 27, Switzerland (tel. +41 22 791 3264; fax: +41 22 791 4857; e-mail: [email protected]; order on line: http://www.who.int/bookorders) TRS946 cover.indd 2 28.11.2007 11:57:11:57:3333 This report contains the collective views of an international group of experts, and does not necessarily represent the decisions or the stated policy of the World Health Organization WHO Technical Report Series 946 THE SELECTION AND USE OF ESSENTIAL MEDICINES Report of the WHO Expert Committee, 2007 (including the 15th Model List of Essential Medicines) Geneva 2007 WHO Library Cataloguing-in-Publication DataPublications of the World Health Organization enjoy copyright protection in accordance with the WHO Library Cataloguing-in-Publication Data WHO Expert Committee on the Selection and Use of Essential Medicines (15th: 2007: Geneva, Switzerland) The selection and use of essential medicines: report of the WHO Expert Committee, 2007: (including the 15th model list of essential medicines). (WHO technical report series; no. 946) 1. Essential drugs - standards. 2. Formularies - standards. 3. Drug information services - organization and administration. 4. Drug utilization. 5. Pharmaceutical preparations - classifi cation. 6. Guidelines. I. Title. II. Title: 15th model list of essential medicines. III. Series. ISBN 978 92 4 120946 5 (LC/NLM classifi cation: QV 55) ISSN 0512-3054 © World Health Organization 2007 All rights reserved. Publications of the World Health Organization can be obtained from WHO Press, World Health Organization, 20 Avenue Appia, 1211 Geneva 27, Switzerland (tel.: +41 22 791 3264; fax: +41 22 791 4857; e-mail: [email protected]). Requests for permission to reproduce or translate WHO publications — whether for sale or for noncommercial distribution — should be addressed to WHO Press, at the above address (fax: +41 22 791 4806; e-mail: [email protected]). The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of the World Health Organization concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted lines on maps represent approximate border lines for which there may not yet be full agreement. The mention of specifi c companies or of certain manufacturers’ products does not imply that they are endorsed or recommended by the World Health Organization in preference to others of a similar nature that are not mentioned. Errors and omissions excepted, the names of proprietary products are distinguished by initial capital letters. All reasonable precautions have been taken by the World Health Organization to verify the information contained in this publication. However, the published material is being distributed without warranty of any kind, either expressed or implied. The responsibility for the interpretation and use of the material lies with the reader. In no event shall the World Health Organization be liable for damages arising from its use. This publication contains the collective views of an international group of experts and does not necessarily represent the decisions or the stated policy of the World Health Organization. Typeset in Switzerland Printed in Switzerland Contents 1. Introduction 1 2. Open session 2 3. Update on current activities 4 3.1 Procedure to update and disseminate the Model List 4 3.2 Proposal for subcommittee on essential medicines for children 6 3.3 Proposal on listing fi xed-dose combination products for infectious diseases 8 3.4 Report from the Advisory Committee on Safety of Medicinal Products 10 3.5 Update of dosage forms and strengths for products on the Model List 10 3.6 Rare diseases proposal 12 3.7 Procedure for updating the content of the Interagency Emergency Health Kit 13 3.8 Late agenda item on medicines for acute care 14 3.9 Report on WHO Model Formulary 14 3.10 Report on Drug Bulletin manual 15 3.11 Review of proposal regarding critically important antibiotics 15 3.12 Advice on draft resolution on rational use of medicines 16 4. Changes made in revising the Model List by section: medicines for all populations 18 4.1 Section 2: addition of prolonged-release morphine 18 4.2 Section 6.1: deletion
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